ASMCA – American Samoa Medical Center

Please inform your patients that LBJ pharmacy does NOT stock Albuterol and Ipratropium products manufactured by Dey L.P.

The U.S. Food and Drug Administration today advised consumers not to use certain respiratory medications purchased after Sept. 8, 2009 and manufactured by Dey L.P., a subsidiary of Mylan Inc., because the medications might have been part of a shipment being transported on a tractor-trailer stolen in Tampa, Fla., on Sept. 8, 2009.

The respiratory medications, Ipratropium Bromide Inhalation Solution, 0.02%, and Albuterol Sulfate Inhalation Solution, 0.083%, unit-dose vials, have not been recovered and may be dangerous to use because the drugs may not have been stored and handled properly.

Dey issued an advisory on Sept. 11, 2009 regarding the theft. Although the FDA is not aware of any reports of adverse events, the agency is advising patients who use these respiratory medications to check to see if products received or purchased after Sept. 8, 2009.

FDA is requiring a Boxed Warning for promethazine hydrochloride injection, USP products to better communicate the risks of severe tissue injury associated with administration of this drug.  Perivascular extravasation, unintentional intra-arterial injection and intraneuronal or perineuronal infiltration of the drug may result in irritation and tissue damage, including gangrene. The Boxed Warning will remind practitioners that due to the risks of intravenous injection, the preferred route of administration is deep intramuscular injection and that subcutaneous injection is contraindicated.

This action is based on FDA’s analysis of post-marketing reports of severe tissue injury, including gangrene, requiring amputation following intravenous administration of promethazine as well as FDA’s review of the current prescribing information for these products.  FDA has determined that the presentation, organization, and content of the prescribing information should be revised to more effectively communicate the risk of severe tissue injury following intravenous administration.

In addition to the Boxed Warning, FDA is requiring a revision to the Dosage and Administration section to increase the visibility and accessibility of specific recommendations for the maximum concentration (25 mg per mL) and rate of administration (25 mg per minute) when intravenous administration of promethazine is required.

FDA is requiring the changes to the prescribing information under the authorities granted to FDA by the Food and Drug Administration Amendments Act (FDAAA) of 2007.

Promethazine hydrochloride injection, USP is approved for a variety of uses including allergic reactions, sedation, motion sickness, nausea, and vomiting associated with anesthesia and surgery, and as an adjunct to analgesics for control of postoperative pain.

Click here for full article and considerations for healthcare:

The U.S. Food and Drug Administration announced today that it has approved four vaccines against the 2009 H1N1 influenza virus. The vaccines will be distributed nationally after the initial lots become available, which is expected within the next four weeks.

“Today’s approval is good news for our nation’s response to the 2009 H1N1 influenza virus,” said Commissioner of Food and Drugs Margaret A. Hamburg, M.D. “This vaccine will help protect individuals from serious illness and death from influenza.”

The vaccines are made by CSL Limited, MedImmune LLC, Novartis Vaccines and Diagnostics Limited, and sanofi pasteur Inc. All four firms manufacture the H1N1 vaccines using the same processes, which have a long record of producing safe seasonal influenza vaccines.

”The H1N1 vaccines approved today undergo the same rigorous FDA manufacturing oversight, product quality testing and lot release procedures that apply to seasonal influenza vaccines,” said Jesse Goodman, M.D., FDA acting chief scientist.

Based on preliminary data from adults participating in multiple clinical studies, the 2009 H1N1 vaccines induce a robust immune response in most healthy adults eight to 10 days after a single dose, as occurs with the seasonal influenza vaccine.

For Article Click here

DRUG ALERT FOR HEALTH CARE PROVIDERS:

FDA ALERT [07/30/2009]: FDA has now approved the first single-ingredient oral colchicine product, Colcrys, for the treatment of familial Mediterranean fever (FMF) and acute gout flares. Oral colchicine has been used for many years as an unapproved drug with no FDA-approved prescribing information, dosage recommendations, or drug interaction warnings.

During the drug application review, FDA identified two previously uncharacterized safety concerns associated with the use of colchicine (marketed as Colcrys).

Click here for article.

Talofa lava and Welcome to the American Samoa Medical Center Blog.

Through blogs we hope to provide our community and our providers with up-to-date information from your American Samoa health experts. We hope that through the use of this technology we can disseminate and get educational material out to our patients and providers to improve the quality of care through education and providing information.

Fa’afetai tele lava ma ia manuia.

The American Samoa Medical Center Authority